Breast CancerSENOCOHORTNCT07833891
Senocohort: Identification of Predictive Biomarkers in Breast Cancer Treatment
An observational study of Breast Cancer and Breast Cancer (Triple Negative Type), run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Breast cancer is a heterogeneous disease with multiple molecular subtypes, each requiring tailored therapeutic strategies. The recent introduction of targeted therapies, immunotherapies, and antibody-drug conjugates has expanded treatment options, yet their efficacy varies depending on tumor subtype. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Breast Cancer (Triple Negative Type)
- What is being tested?
- Patients follow-up
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Oct 2041
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 or older with a histologically confirmed diagnosis of breast cancer, treated at the Saint-Louis Hospital senology and breast surgery departments. Emphasis will be placed on hormone receptor-negative subtypes.
Who may be able to join
- Age ≥ 18 years
- Histologically confirmed breast cancer
- Managed at Saint-Louis Hospital
- No opposition to participation in research
- Affiliation to the French national health system
Who cannot join
- Expressed opposition to research
- Legal incapacity or under legal protection
- Patients under State Medical Aid (AME)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Recherche de Biomarqueurs prédictifs de réponse ou de résistance Dans Les Traitements Des Cancers du Sein
Breast cancer is a heterogeneous disease with multiple molecular subtypes, each requiring tailored therapeutic strategies. The recent introduction of targeted therapies, immunotherapies, and antibody-drug conjugates has expanded treatment options, yet their efficacy varies depending on tumor subtype. This non-interventional study aims to identify novel predictive biomarkers of response or resistance to these emerging therapies. The Senocohort study will prospectively collect clinical, biological, imaging, and organoid-derived data from breast cancer patients, with a focus on hormone receptor-negative tumors. The ultimate goal is to improve precision medicine strategies and patient stratification
Read the detailed description
Senocohort is a prospective, bicentric cohort study designed to collect clinico-biological data and establish a biobank of patient-derived tumor organoids (PDOs) from residual tissue samples obtained during routine care. The aim is to identify new multimodal biomarkers (molecular, cellular, and imaging) predictive of response or resistance to breast cancer therapies, with evaluation based on progression-free survival. The study targets an enriched population of hormone receptor-negative breast cancers, particularly triple-negative subtypes, which currently lack effective targeted treatments. Samples will be used for genomic analyses, PDO development, and circulating biomarker studies, with 10 years of clinical follow-up.
- Being tested
- Patients follow-up
- Keywords
- hormone receptor-negative breast cancer, Breast neoplasms, Biomarkers, Precision medicine, Tumor organoids, Predictive biomarkers, Triple-Negative Breast Neoplasms, Circulating DNA, Patient-Derived Organoid, Immunotherapy
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients follow-upOther
Blood sampling, residual tissue material collection and clinical data collection
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Patients at Saint-Louis Hospital | Patients with newly diagnosed or recurrent breast cancer managed at the breast surgery and senology units. Residual tumor tissue, blood, and clinical data will be collected for analysis. Receives: Other: Patients follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Predictive Multimodal Biomarkers identified
Discovery and validation of molecular, cellular, and imaging biomarkers associated with response or resistance to therapies, evaluated on progression-free survival.
Measured: Up to 10 years
Secondary outcomes (3)
Overall Survival Analysis by Biomarker Subgroup
Evaluation of overall survival based on biomarker-defined subgroups.
Measured: Up to 10 years
Multimodal biomarker performance
Assessment of the added value of combining multiple types of biomarkers (e.g., genomic + imaging).
Measured: Up to 10 years
Drug Sensitivity in PDO Models
Ex vivo response of PDOs to approved or experimental therapies, correlated with clinical outcomes.
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2031 (estimated)
- Study completion1 Oct 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833891
- Sponsor's protocol ID
- APHP241257
- Acronym
- SENOCOHORT
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recherche de Biomarqueurs prédictifs de réponse ou de résistance Dans Les Traitements Des Cancers du Sein
- ClinicalTrials.gov ID
- NCT07833891
- Acronym / sponsor ID
- SENOCOHORT / APHP241257
- Keywords
- hormone receptor-negative breast cancer, Breast neoplasms, Biomarkers, Precision medicine, Tumor organoids, Predictive biomarkers, Triple-Negative Breast Neoplasms, Circulating DNA
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2031 (estimated)
- Study completion
- 1 Oct 2041 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast cancer is a heterogeneous disease with multiple molecular subtypes, each requiring tailored therapeutic strategies. The recent introduction of targeted therapies, immunotherapies, and antibody-drug conjugates has expanded treatment options, yet their efficacy varies depending on tumor subtype. This non-interventional study aims to identify novel predictive biomarkers of response or resistance to these emerging therapies. The Senocohort study will prospectively collect clinical, biological, imaging, and organoid-derived data from breast cancer patients, with a focus on hormone receptor-negative tumors. The ultimate goal is to improve precision medicine strategies and patient stratification
Detailed description
Senocohort is a prospective, bicentric cohort study designed to collect clinico-biological data and establish a biobank of patient-derived tumor organoids (PDOs) from residual tissue samples obtained during routine care. The aim is to identify new multimodal biomarkers (molecular, cellular, and imaging) predictive of response or resistance to breast cancer therapies, with evaluation based on progression-free survival. The study targets an enriched population of hormone receptor-negative breast cancers, particularly triple-negative subtypes, which currently lack effective targeted treatments. Samples will be used for genomic analyses, PDO development, and circulating biomarker studies, with 10 years of clinical follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Patients at Saint-Louis Hospital | – | Other: Patients follow-upPatients with newly diagnosed or recurrent breast cancer managed at the breast surgery and senology units. Residual tumor tissue, blood, and clinical data will be collected for analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 or older with a histologically confirmed diagnosis of breast cancer, treated at the Saint-Louis Hospital senology and breast surgery departments. Emphasis will be placed on hormone receptor-negative subtypes.
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Histologically confirmed breast cancer
- Managed at Saint-Louis Hospital
- No opposition to participation in research
- Affiliation to the French national health system
Key exclusion criteria (3 listed)
- Expressed opposition to research
- Legal incapacity or under legal protection
- Patients under State Medical Aid (AME)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients follow-upBlood sampling, residual tissue material collection and clinical data collection | Other | Breast Cancer Patients at Saint-Louis Hospital |
Primary outcome
Number of Predictive Multimodal Biomarkers identified
Time frame: Up to 10 years
Discovery and validation of molecular, cellular, and imaging biomarkers associated with response or resistance to therapies, evaluated on progression-free survival.
3 secondary outcomes
Overall Survival Analysis by Biomarker Subgroup
Time frame: Up to 10 years
Multimodal biomarker performance
Time frame: Up to 10 years
Drug Sensitivity in PDO Models
Time frame: Up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Breast Cancer (Triple Negative Type), run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luis Texeira, MD PhD (01 42 49 96 13 ext. +33, luis.teixeira@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Predictive Multimodal Biomarkers identified (time frame: Up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.